# K992348: Synthes Spiral Blade for Humeral Nail (SBHN)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 23, 1999 after 71 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Unreamed Humeral Nail (a.k.a. Solid Humeral Nail): named in the summary without a submission number

## Most influential descendants
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants (2018), 2 descendants of its own
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (2026), 0 descendants of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own
- K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (2017), 0 descendants of its own

## Recalls of this device
- Feb 25, 2010 · Not classified · Z-1548-2010: potential compatibility issue
- Feb 25, 2010 · Not classified · Z-1549-2010: potential compatibility issue

## Indications for use
Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

Source page: https://510kreport.com/device/K992348
Methodology: https://510kreport.com/methodology